Zabir Macci, director of eCOA business strategy & sales engineering at IQVIA, describes how to navigate global regulatory guidance for successful multinational clinical trials.
Key insights:
- Multinational clinical trials uncover variabilities in results, such as gene and socioeconomic factors, and bring them forward for consideration in analysis.
- Clinical trials can become complex when conducted on a global scale as regulations vary from country to country.
- An electronic clinical outcome assessment (eCOA) is a key tool for alleviating participant burden in multinational clinical trials, used by regulators to measure the effectiveness of a treatment and capture real-time participant insights.
The rising popularity of hybrid clinical trials has created more opportunities for multinational clinical studies, uniting patients across the world to participate in research for the same disease. While the diverse trove of data yielded from these trials provides unprecedented opportunities for the innovation of breakthrough treatments, compliance can remain a challenge. Regulatory guidance is continuously evolving and can be vague in describing how data can and cannot be utilised. This becomes increasingly complex when clinical trials are conducted on a global scale as regulations vary from country to country.
When planning a multinational clinical trial, sponsors need a comprehensive and robust set of technology solutions to monitor fluctuating regulations, assist with recruitment and site management in unfamiliar areas and address language barriers with accurate translations.
Multinational clinical trials enrich data and drive outcomes
Multinational trials are critical to the clinical research process for several reasons. From an efficacy standpoint, collecting data across a diversified population provides further context on the overall effectiveness of a treatment. Stakeholders must know whether a drug impacts an Asian male differently than a Caucasian male, for example, to determine if genetic factors are at play.
Additionally, there are many socioeconomic factors across countries that create barriers and disparities. Multinational clinical trials uncover these variabilities and bring them forward for consideration in analysis. The importance of this approach was illustrated throughout the Covid clinical research process, wherein certain vaccines were shown to be more effective in some populations than others. Accounting for the Pharmacokinetic-Pharmacodynamic (PKPD) variations per geography or region for not only race, but also socioeconomic factors strengthen the analysis process, leading to more informed decision making.
Finally, participants with rare diseases rely heavily on clinical research. In some instances, an illness may be so rare that it is necessary to recruit participants from across the globe. Certain rare diseases can also be very local to a specific region. Hence, for some populations, multinational clinical trials are one of the only ways to improve their quality of life and uncover new treatments for their condition.
Regulatory challenges and opportunities
Given that stakeholders must stay apprised of a vast regulatory landscape, compliance is inherently more complex in multinational clinical trials. Regulatory guidelines are continuously evolving, and monitoring these changes is no simple task. In the planning phase, a global Contract Research Organisation (CRO) can provide stakeholders with a central repository that allows them to navigate through data and regulations, whether they were updated two years ago or two days ago.
Seasoned CROs work with officials globally to understand the compliance needs in each specific country. Take geofencing, for example, which requires investigators to keep data local within the boundaries of where the trial is taking place. If regulations require that the server used in the trial resides within that country, it is critical for sponsors to work with solution providers that are prepared to support such infrastructure. In countries like China with more stringent regulations for data localisation, there are alternative solutions related to anonymisation and personal data protection. In this case, anonymised patient IDs can be used to ensure data is only visible to local clinics and investigators, while still allowing the CRO to manage the trial and ensure that quality, safety and efficiency are maintained.
Beyond regulatory guidelines, a global CRO helps determine which countries to select based on the targeted ailment, site availability, infrastructure setup, recruitment, staffing/site management and data collection. This ultimately gives sponsors the lay of the land in unfamiliar countries, connecting them with experienced local teams who know the language and culture of the trial location. These teams are prepared to manage participant data and bring it to the larger dataset for analysis.
Addressing language barriers
An electronic clinical outcome assessment (eCOA) is a key tool for alleviating participant burden in multinational clinical trials. These digital assessments are an important benchmark used by regulators to measure the effectiveness of a treatment, as they provide a direct way to capture real-time participant insights and track progress outside the confines of the site environment.
To get the most out of this data in a multilingual trial, accurate translations within the assessment are critical – but this can be an incredibly time-consuming process. Sponsors should carefully select an eCOA solution with processes that eliminate back-and-forth communication with third-party translation services, which can delay activation by about eight weeks on average. Fortunately, there are solution providers who can complete the entire translation process digitally with in-house translation services, or through a pre-built assessment in many cases.
Complex research requires robust technology solutions
While multinational clinical trials are complex, they yield rich datasets that accelerate the development of breakthrough therapies and treatments. For many, especially those suffering with rare diseases, multinational clinical trials are the gateway to a higher quality of life. Throughout the planning process, sponsors should ensure their partners are providing the necessary intelligent technology tools to select the right countries for their trial, adhere to the regulatory requirements of those countries, recruit participants and address any language barriers with multilingual assessments.